NCT01540955

Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Cognitive complaints---difficulties with memory, concentration, and planning-are commonly reported after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints and test performance, in comparison to women who will receive the same intervention at a later time (wait-list control). Women will also have an EEG test performed before and after the intervention program to see if improvements in cognitive complaints and performance can be documented by examining the EEG.

Detailed description

Previous pilot work (non-randomized, pre-post design) has shown that this intervention was effective in improving post-intervention cognitive complaints and neuropsychological (NP) test performance. Because practice effects may influence NP performance, it is important to compare the intervention participants to women who are not exposed to the intervention. Thus, this randomized controlled trial will compare the active intervention to a control group of patients who will receive the intervention at a delayed time point. The primary outcomes are improvements in cognitive complaints and NP test performance 2 months after completion of the intervention program. Quantitative EEG (QEEG) measurements will be used as a secondary exploratory endpoint to see if this may be an effective biomarker of cognitive performance.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Improving Cognition with group intervention	Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-02-29
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States